FDA has issued a Draft Guidance for comment describing the agency’s proposed recommendations for including relevant information about oncology drug labels that have been approved for use in combination drug regimens.
Cross-labeling is the inclusion of information in product labeling of two or more oncology drugs approved in a combination regimen for a specific indication. The intent is to provide information in product labeling for the drugs used in a combination regimen that are complementary and consistent and not to include all of the same information in labeling for each drug in the combination regimen.
“Oncology drug applications to the FDA often add investigational drugs to current regimens to create new combination regimens with greater efficacy or safety. Sponsors have traditionally not requested cross-labeling—making changes to the labeling of a previously approved drug that describes how to use that drug in a new regimen,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“However, recently we’ve seen an increase in the number of applications that have proposed cross-labeling for oncology drug combination regimens,” he said.
The draft guidance includes procedures for cross-labeling application submissions and considerations for selected sections in the “Full Prescribing Information” part of the drug label.
“We are issuing today’s draft guidance to serve as a starting point for discussions between the FDA and sponsors of oncology drugs, as well as the medical and academic communities, and the public on including relevant information in labeling for oncology drugs approved for use in a combination regimen,” Pazdur said. “Cross-labeling can provide clear, consistent and accessible information to guide the safe and effective use of cross-labeled drugs in an oncology treatment regimen.”
